Key points:
- UltraSight AI Guidance is designed for users without extensive ultrasound imaging expertise, enhancing clinical efficiency.
- It Guides users through ten standard cardiac views, offering a complete tool for cardiac imaging.
- Received FDA’s pre-market authorization on July 24, 2023, affirming its reliability and effectiveness in medical settings.
UltraSight AI Guidance
UltraSight AI Guidance leverages machine learning and artificial intelligence (AI) to offer dynamic, real-time guidance for medical practitioners. This technology serves as an accessory to compatible general-purpose diagnostic ultrasound systems.
Its primary application is two-dimensional transthoracic echocardiography (2D-TTE) for adult patients. This guidance is crucial for correctly positioning and orienting the ultrasound transducer, ensuring the acquisition of diagnostic-quality tomographic views of the heart.
Uses
The system is designed to assist users who may not have extensive expertise in ultrasound imaging, making it more accessible and efficient in clinical settings. The software can guide users through ten standard cardiac views, making it a comprehensive tool for cardiac imaging.
This system is developed by UltraSight Ltd. and received FDA’s pre-market authorization on July 24th 2023.
Similar devices: Caption Health’s Caption Guidance
Reference
FDA “K223347 Ultrasight AI 510(k) Premarket Notification.” Accessed March 2, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223347.
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